Report: mHealth regulation still murky

By Brian Dolan
01:50 am

As part of its recent interest in all things mobile health, a headline over at Scientific American this week asked a weighty question: Should medical apps face governmental oversight? The answer to that question is one we have tracked consistently over the past year and a half, but the quick and easy version of it might be: They already do.

A month ago, MobiHealthNews broke the story of the FDA's removal of MIMvista's radiology imaging iPhone app from Apple's AppStore just months after the iPhone's app marketplace opened in 2008. Since then MIM has been denied a 510(k) after waiting some 18 months and is in the process of filing a premarket approval application (which is not cheap).

The Scientific American article points to another app that is causing a stir among regulators: "Because of a programming error, allergy information for a patient failed to display on a clinical decision support app." That anecdote was among those shared by Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, during his recent testimony to the FDA's health technology committee.

Our contributing writer Bradley Merrill Thompson has penned a number of in-depth essays about wireless health regulation. Revisit the series here:

Washington signals possible FDA regulation of mHealth
How to avoid FDA mHealth regulation
Should mHealth companies want FDA regulation?
How to get FDA to clear a mobile health app
Step-by-step: FDA regulation of wireless health
FDA may regulate certain mobile phones, accessories


The latest news in digital health delivered daily to your inbox.

Thank you for subscribing!
Error! Something went wrong!